Arthrosamid vs. Steroid for the Management of Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthrosamid® 2.5% iPAAG injectable implant, Steroid Drug.
- Who it may be relevant to
- Registry conditions: Osteo Arthritis Knee, Osteoarthritis, Intraarticular Injection. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised Control Trial of the Use of an Intraarticular Hydrogel Arthrosamid® vs. Steroid for the Non-operative Management of Knee Osteoarthritis
Overview
This study will be a randomised control trial of the use of intra-articular Arthrosamid® a novel intraarticular hydrogel vs. standard of care (steroid and local anaesthetic) for the non-operative management of knee osteoarthritis.
Detailed description
The authors aim is to study the effect of this intra-articular medication by randomising approximately 100 patients to the treatment arm of the study Arthrosamid, and 100 patients to the control arm (which will be the current standard of care currently provided at CNOH: intra-articular steroid and bupivacaine).
Patients will be referred from Orthopedic clinics and will be eligible if have symptomatic knee pain and arthritis show on prior imaging.
Patients will be given information about the study and given time to choose to be enrolled. They will sign consent forms prior to the study.
They will be randomized into 2 groups. Both will get single knee joint injections into 1 knee. Either Arthrosamid or intra-articular steroid and bupivacaine. They will be blinded to what they have gotten. They will be followed up at 3, 6 , 12 and 18 months with MRI imaging and functional assessment to assess which is better.
Interventions
- Device Arthrosamid® 2.5% iPAAG injectable implant
Arthrosamid is a non-biodegradable, 2.5% polyacrylamide hydrogel (iPAAG) injection designed as a long-lasting, non-surgical treatment for knee osteoarthritis. It acts as a synovial implant that provides cushioning, reduces pain, and improves mobility for up to 3-4 years, often delaying the need for knee replacement surgery. - Drug Steroid Drug
dexamethasone 8mg, methylprednisolone 80mg and bupivacaine 5ml 0.25%, intra articular injection
Primary outcome measures
- Western Ontario and McMaster Universities Arthritis Index (WOMAC). [Time frame: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.]
Secondary outcome measures (3)
- MRI knee [Time frame: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.]
- EuroQol-5 Dimension-5 Level health questionnaire. [Time frame: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.]
- Visual numerical pain rating scale (VNS) [Time frame: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.]
Eligibility criteria
Inclusion criteria
- Adults
- Symptomatic single side knee pain.
- Patients with diagnosis of knee osteoarthritis radiographic Kellgren and Lawrence system OA grade II-III-IV on x ray or MRI.
Exclusion criteria
- Inflammatory conditions,
- Cancer,
- acute infection,
- pregnancy and breastfeeding.
- Uncontrolled diabetes mellitus,
- Joint diseases in the knee, such as rheumatoid arthritis or gout, history of knee surgery with metallic implant.
- If patient has undergone knee arthroscopy in past 6 months.
- Intra-articular injection of corticosteroids during the previous 3 months, intra-articular injection of other drugs, such as hyaluronic acid over the previous 1 year.
- Contraindications for intra-articular injection, such as thrombocytopenia, coagulopathy, articular infection of knee, impairment of immunity.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Ireland · 1 center
- Cappagh National Orthopaedic Hospital — Dublin
Identifiers
NCT: NCT07489521 · NOHC-2025-ETH-MB-CEO-388